Dg Health Tussin

Description

DG™|health is a maximum strength formulation designed for adults aged 12 and over, providing relief for multiple symptoms associated with cough, cold, and flu. This product contains a combination of active ingredients, including acetaminophen as a pain reliever and fever reducer, dextromethorphan hydrobromide as a cough suppressant, guaifenesin as an expectorant, and phenylephrine hydrochloride as a nasal decongestant.

The formulation is designed to alleviate symptoms such as cough, sore throat, body aches, fever, nasal congestion, and chest congestion. It is non-drowsy and presented in a raspberry flavor. The product is available in a liquid dosage form, with a total volume of 4 fluid ounces (118 mL).

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with the common cold or flu. Specifically, it addresses the following symptoms: cough due to minor throat and bronchial irritation, nasal congestion, sinus congestion and pressure, minor aches and pains, sore throat, headache, and fever. Additionally, this drug aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes and enhancing the productivity of coughs.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children aged 12 years and older are advised to take 20 mL every 4 hours as needed. It is imperative that no more than 5 doses are taken within a 24-hour period. Healthcare professionals should emphasize the importance of adhering to the recommended dosage, as exceeding this may result in serious liver damage.

The dosing cup provided with the product must be used for accurate measurement; it is essential to keep the dosing cup with the product at all times to ensure proper administration. This product is not intended for use in children under 12 years of age.

Contraindications

Use of this product is contraindicated in the following situations:

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or those who have discontinued MAOI therapy within the past two weeks. The combination may lead to serious interactions. If there is uncertainty regarding the presence of an MAOI in a prescription, consultation with a healthcare professional is advised.

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose.

This product should not be used in individuals with a known allergy to it or any of its ingredients, as this may result in severe allergic reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that exceeding 4,000 mg of acetaminophen within a 24-hour period, using other medications containing acetaminophen concurrently, or consuming three or more alcoholic drinks daily while using this product significantly increases the risk of liver injury.

Acetaminophen may also provoke severe skin reactions. Symptoms such as skin reddening, blisters, or rash may indicate a serious allergic response. In the event of a skin reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

In cases of severe sore throat that persists for more than two days or is accompanied by fever, headache, rash, nausea, or vomiting, patients should be advised to consult a physician promptly.

General precautions should be taken for patients with specific health conditions. Prior to use, individuals should consult a healthcare provider if they have liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a cough associated with excessive phlegm. Additionally, those with persistent or chronic coughs, such as those resulting from smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before using this product. It is also essential to consult a doctor or pharmacist if the patient is taking warfarin, a blood-thinning medication.

In the event of an overdose, immediate medical attention is crucial. Patients should be instructed to contact a Poison Control Center at 1-800-222-1222 or seek emergency medical help without delay, as prompt intervention is vital for both adults and children, even in the absence of noticeable symptoms.

Patients should be advised to discontinue use and contact their healthcare provider if they experience nervousness, dizziness, or sleeplessness. Additionally, worsening pain, cough, or nasal congestion lasting more than seven days, fever that worsens or persists beyond three days, the presence of redness or swelling, the emergence of new symptoms, or a cough that recurs with a rash or headache should be evaluated as these may indicate a serious underlying condition.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed 4,000 mg in 24 hours, use other medications containing acetaminophen concurrently, or consume three or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions associated with acetaminophen, which may manifest as skin reddening, blisters, or rash. In the event of a skin reaction, it is imperative to discontinue use and seek medical assistance immediately.

Participants experiencing a severe sore throat that persists for more than two days, or is accompanied by fever, headache, rash, nausea, or vomiting, should consult a healthcare professional promptly.

Patients are advised to stop use and contact a doctor if they experience nervousness, dizziness, or sleeplessness; if pain, cough, or nasal congestion worsens or lasts more than seven days; if fever worsens or lasts more than three days; if redness or swelling occurs; if new symptoms arise; or if a cough recurs or occurs with a rash or headache that persists, as these may indicate a serious condition.

Before using this product, patients with liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or trouble urinating due to an enlarged prostate gland should consult a healthcare provider. Additionally, those with a cough that produces excessive phlegm or a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

Patients taking the blood-thinning medication warfarin should also consult a doctor or pharmacist before using this product.

In the event of an overdose, it is critical for patients to seek medical help or contact a Poison Control Center immediately at 1-800-222-1222, as prompt medical attention is essential for both adults and children, even if no signs or symptoms are apparent.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking warfarin, a blood-thinning agent, due to the potential for increased bleeding risk.

The use of this medication is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain treatments for depression, psychiatric disorders, or Parkinson’s disease. Additionally, it should not be used for at least two weeks following the discontinuation of an MAOI.

Co-administration with any other product containing acetaminophen, whether prescription or over-the-counter, is not recommended. Patients are advised to verify the presence of acetaminophen in other medications by consulting a healthcare professional if uncertain.

Packaging & NDC

Below are the non-prescription pack sizes of Dg Health Tussin (acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 20 mL every 4 hours.

In the event of an overdose, it is crucial to seek prompt medical attention for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing infant.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating mothers.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they experience difficulty urinating due to an enlarged prostate gland. It is essential to assess renal function and consider potential dosing adjustments or monitoring requirements based on the degree of impairment.

Hepatic Impairment

Patients with hepatic impairment should be advised of the potential risks associated with the use of this product, particularly due to its acetaminophen content. Severe liver damage may occur if the total daily dosage exceeds 4,000 mg of acetaminophen, if it is taken concurrently with other medications containing acetaminophen, or if the patient consumes three or more alcoholic drinks daily while using this product.

It is recommended that patients with known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss any necessary dosage adjustments or monitoring requirements. Regular monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate medical care as needed.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the understanding of potential risks associated with the compound in nonclinical settings.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: skin reddening, blisters, and rash.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222 in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have taken one within the past two weeks. It is important for patients to consult with their doctor or pharmacist if they are uncertain whether their prescription medication contains an MAOI.

Healthcare providers should emphasize that patients must not use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are unsure about the presence of acetaminophen in their other medications, they should be encouraged to ask their doctor or pharmacist.

Patients should be cautioned against using this product if they have a history of allergic reactions to it or any of its ingredients. They should be instructed to discontinue use and consult a doctor if they experience symptoms such as nervousness, dizziness, or sleeplessness.

Additionally, patients should be advised to stop using the product and seek medical advice if their pain, cough, or nasal congestion worsens or persists for more than seven days, if their fever worsens or lasts more than three days, or if they notice any redness or swelling. They should also be informed to consult a doctor if new symptoms arise or if a cough returns or occurs alongside a rash or headache that lasts, as these may indicate a serious condition.

When using this product, patients must be reminded to adhere strictly to the recommended dosage and not exceed it. Healthcare providers should encourage patients to consult a doctor before use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Patients with a cough that produces excessive phlegm or those with a persistent or chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should also seek medical advice prior to use.

Lastly, patients taking the blood-thinning medication warfarin should be advised to consult their doctor or pharmacist before using this product.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at a temperature range of 20-25°C (68-77°F). Refrigeration is not recommended, as it may compromise the integrity of the product. Proper storage conditions must be maintained to ensure the product's efficacy and safety.

Additional Clinical Information

Patients should be aware that the medication is administered orally, with a recommended dosage of 20 mL every 4 hours for adults and children aged 12 years and older. It is not recommended for use in children under 12 years of age.

Clinicians should counsel patients to consult a doctor prior to use if they have any of the following conditions: liver disease, heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate, or a persistent cough associated with excessive phlegm, smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients taking the anticoagulant warfarin should seek advice from a healthcare professional before use. Pregnant or breastfeeding individuals should also consult a health professional. It is crucial to keep the medication out of reach of children, and in the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222.

Drug Information (PDF)

This file contains official product information for Dg Health Tussin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)